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Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by T1D and if probiotic supplementation may beneficially modulate this inflammatory state.
Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood samples will be analyzed before and after the six week course of probiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSL#3 | Experimental | Participants will be given the probiotic supplement VSL#3, a commercially available product. VSL#3 is taken by mouth, either once or twice daily, and is dispensed in sachets, each containing 450 billion colony forming units of bacterial strains. Participants will undergo a screening visit. They will be asked to provide a stool sample by the next visit. Within 3 weeks they will return with a stool sample and receive the VSL#3 sachets as well as another stool collection kit. After 6 weeks of taking VSL#3, they will return for their final visit, with their stool sample. Blood will be drawn at the second and third visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Dietary Supplement | VSL#3 is a commercially available probiotic supplement manufactured and distributed by Alfasigma USA, Inc of Covington, Louisiana, USA. As with other probiotics, VSL#3 is considered a supplement and is not FDA-approved or regulated. VSL#3 contains eight probiotic strains: bifidobacteria (B. longum, B. infantis, and B. breve), lactobacilli (L. acidophilus, L. casei, L. bulgaricus, and L. plantarum) and Strepococcus thermophiles. |
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in Plasma-Induced Transcriptional Analysis | Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis | 2 years (study duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Microbiota | Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function | 2 years (study duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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